FLEXIBLE SYSTEM TO ADVANCE INNOVATIVE RESEARCH FOR CANCER DRUG DISCOVERY
BY SMALL BUSINESSES (FLAIR) – SBIR/STTR INITIATIVE
RELEASE DATE: February 25, 2003
PA NUMBER: PAR-03-074
EXPIRATION DATE: November 17, 2003, unless reissued.
National Cancer Institute (NCI)
(http://www.nci.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.395
LETTER OF INTENT RECEIPT DATES: June 16, 2003 and October 17, 2003
APPLICATION RECEIPT DATE: July 14, 2003 and November 14, 2003
This Program Announcement (PAR) replaces PA-01-091, which was published
in the NIH Guide on May 7, 2001.
THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanisms of Support
o Project Period and Amount of Award
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Receipt and Review Schedule
o Required Federal Citations
PURPOSE OF THIS PAR
Discovery and development of new drugs and biologicals for cancer
treatment, including gene therapy and drug delivery approaches, normally
involve lengthy and costly projects. The multiple components of the
overall process including discovery, efficacy testing, development of
lead agents, toxicology and pharmacology, Investigational New Drug
Application (IND) filing to the Federal Drug Administration (FDA), and
clinical evaluation, may require years and several million dollars.
The small business community is an active participant in the cancer
therapy discovery effort. Thus it is important that their innovative
ideas be supported. The Small Business Innovation Research (SBIR) and
Small Business Technology Transfer (STTR) programs were developed to
support innovative research with a commercial intent by small
businesses. This PAR provides a flexible system within the SBIR and
STTR programs to accommodate the special needs of the complex discovery
and development process, at least partially, from basic discovery
through proof of principle demonstration in clinical trials. It is
hoped that this initiative will stimulate drug discovery research
efforts in the small business community. It will provide opportunity to
small businesses to develop new treatments for rare cancers that are
often overlooked because of small market considerations.
NOTICE: This PAR must be read in conjunction with the current OMNIBUS
SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, CENTERS FOR DISEASE
CONTROL AND PREVENTION, and FOOD AND DRUG ADMINISTRATION FOR SMALL
BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY
TRANSFER (STTR) GRANT APPLICATIONS. See
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). All of the
instructions within the SBIR/STTR Omnibus Solicitation apply with the
following exceptions:
o Special receipt dates
o Initial review convened by the Division of Extramural Activities,
National Cancer Institute (NCI)
o Additional review considerations
o More flexible time and budget specifications
o Special provision for competitive renewal of certain R44 or R42 awards
o Special provision for competitive supplements to support extended
development studies including clinical trials.
RESEARCH OBJECTIVES
Recent advances in all branches of medical sciences provide new insight
into the underlying mechanisms in malignancy and suggest new targets and
approaches for the treatment and prevention of adult and pediatric
cancers. For example, key growth regulatory pathways and genes mutated
in cancer cells are being identified, array technology for expression of
thousands of genes as well as computer-assisted evaluation of data are
available, new technologies in chemistry which allow facile synthesis of
millions of new chemicals, and high resolution structures of important
target proteins are becoming available. NCI has made approaches for drug
discovery based on these directions a high priority: see
http://plan2002.cancer.gov. Translation of these new discoveries and
innovations into clinical benefit for the cancer patient is essential;
however, the process is lengthy and costly. Following initial discovery
and lead optimization, potential drugs must undergo a series of rigorous
pre-clinical evaluations that may culminate in a clinical trial. The
actual procedures for this process vary somewhat with each agent to be
tested, and, with innovative approaches often required for new agents,
an extensive research effort may be necessary for successful development
and eventual commercialization. For this PAR, the term "drug" is used
broadly. It includes small molecules, biologicals, vaccines, gene
therapy, or drug delivery approaches designed to make therapy more
selective for cancer cells. The objective of this PAR is to provide a
flexible funding mechanism with regard to budgets and time of award to
support the research activities required to enable small businesses to
bring their innovative efforts for drug discovery and development to
clinical validation.
Projects submitted in response to this PAR should be focused on
discovery and development of a specific agent or class of agents.
Applications devoted to topics relating more generally to drug discovery
such as technology and model development without direct relevance to
development of a specific agent are not appropriate.
Flexibility within the PAR allows for projects to be presented at all
stages of the drug discovery and development process. Projects will be
evaluated on overall innovation, strength of the drug discovery
approach, and probability of clinical success, with less emphasis on the
nature of the specific stage proposed in the application. This latter
aspect is especially important if applications are focused on later
stages of the drug discovery and evaluation process that may be more
routine and often considered less innovative as stand-alone projects.
MECHANISM OF SUPPORT
This PAR uses the SBIR and STTR mechanisms, which are set-aside
programs. As an applicant, you will be solely responsible for planning,
directing, and executing the proposed project. Future unsolicited,
competing- continuation applications based on this project will compete
with all SBIR/STTR applications and will be reviewed according to the
customary peer review procedures. Applications that are not funded in
the competition described in this PAR may be resubmitted as revised
SBIR/STTR applications using the standard receipt dates for NEW
applications described in the current SBIR/STTR Omnibus Solicitation.
This PAR uses the just-in-time concepts. It also uses the modular
budgeting format. Specifically, if you are submitting an application
budget of $100,000 total costs (direct, F&A, and fee) or LESS, use the
modular format and instructions as described in the current SBIR/STTR
Omnibus Solicitation. Otherwise follow the instructions for non-modular
research grant applications.
The SBIR/STTR mechanism requires that the intent of the research be the
commercialization of a product or service.
Except as otherwise stated in this PAR, awards will be administered
under NIH grants policy as stated in the NIH Grants Policy Statement,
March 2001, available at
http://grants.nih.gov/grants/policy/nihgps_2001.
Applications may be submitted for support as Phase I STTR (R41) or Phase
I SBIR (R43) grants; Phase II STTR (R42) or Phase II SBIR (R44) grants;
or the SBIR/STTR FAST-TRACK option as described in the SBIR/STTR Omnibus
Solicitation. Phase II applications in response to this PAR will only
be accepted as competing continuations of previously funded NIH Phase I
SBIR/STTR awards. The Phase II application must be a logical extension
of the Phase I research but not necessarily a Phase I project supported
in response to this PAR. FAST-TRACK applications will benefit from
expedited evaluation of progress following the Phase I feasibility study
for transition to Phase II funding for expanded developmental work.
Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are
available at: http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf.
For the NCI resources available to qualified investigators in support of
research, such as the compound libraries and the natural product
repository, see http://dtp.nci.nih.gov.
PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of
funding support and project duration periods for SBIR and STTR Phase I
and Phase II awards. However, some projects are likely to require
longer time periods and/or larger budgets to accomplish the proposed
aims. Therefore, if adequately justified, budgets up to $300,000 total
costs per year and time periods up to 2 years for Phase I and $750,000
total costs per year and up to 4 years for Phase II can be requested.
Phase II applications that include support for expensive studies
required for IND filing with the FDA and/or clinical trials may request
up to $1 million per year total costs, but the budget must be adequately
justified. For FAST-TRACK applications the total duration of Phase I
plus Phase II cannot exceed 5 years.
Cost-sharing arrangements are encouraged since the SBIR/STTR programs
cannot support all activities that may be required to advance a material
to feasibility demonstration in a clinical trial.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the SBIR/STTR Omnibus
Solicitation. Only small business concerns are eligible to submit
SBIR/STTR applications. A small business concern is one that, on the
date of award for both Phase I and Phase II agreements, meets ALL of the
criteria as described in the current SBIR/STTR Omnibus Solicitation.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs. On an
SBIR application, the principal investigator must have his/her primary
employment (more than 50%) with the small business at the time of award
and for the duration of the project. The Principal Investigator on an
STTR application may be employed with the small business concern or the
participating non-profit research institution as long as s/he has a
formal appointment with or commitment to the applicant small business
concern, which is characterized by an official relationship between the
small business concern and that individual.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PAR and welcome the
opportunity to answer questions from potential applicants. Inquiries
may fall into three areas: scientific/research, peer review and
financial or grants management issues.
Direct your questions about scientific issues to:
George S. Johnson, Ph.D.
Development Therapeutics Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Boulevard, EPN 8152
Bethesda, MD 20892-7456
(For express/courier service: Rockville, MD 20852)
Tel: 301-496-8783
Fax: 301-402-5200
Email: johnsong@exchange.nih.gov
Direct your questions about peer review matters to:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
Direct your questions about financial or grants management matters to:
Mr. Shane Woodward
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd
Bethesda, MD 20892-1750
Telephone: (301) 496-8649
FAX: (301) 496-8601
Email: woodwars@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this PAR
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows NCI staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to Dr. George S.
Johnson at the address provided above under WHERE TO SEND INQUIRIES.
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all competing
SBIR/STTR Phase I, Phase II and Fast-Track applications (new and
revised.) The PHS 398 is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html. Prepare your
application in accordance with the SBIR/STTR Omnibus Solicitation and
the PHS 398. Helpful information for advice and preparation of the
application can be obtained at:
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH
will return applications that are not submitted on the 5/2001 version of
the PHS 398. For further assistance contact GrantsInfo, Telephone:
(301) 435-0714, Email: GrantsInfo@nih.gov.
The SBIR/STTR OMNIBUS SOLICITATION is available electronically through
the NIH, Office of Extramural Research Small Business Funding
Opportunities web site:
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf. The
solicitation contains information about the SBIR and STTR programs,
regulations governing the programs, and instructional information for
submission. Helpful information for preparation of the application can
be obtained at: http://grants.nih.gov/grants/grant_tips.htm.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: This PAR uses the
modular budgeting format. Specifically, if you are submitting an
application budget of $100,000 total costs (direct, F&A and fee) or
less, use the modular format and instructions as described in the
SBIR/STTR Omnibus Solicitation.
USING THE SBIR/STTR LABEL: Attach the appropriate SBIR or STTR label to
the bottom of the face page of the application (MS Word:
http://grants.nih.gov/grants/funding/phs398/labels.doc or PDF:
http://grants.nih.gov/grants/funding/phs398/labels.pdf). Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review.
THE TITLE AND NUMBER OF THIS PAR MUST BE TYPED ON LINE 2 OF THE FACE
PAGE OF THE APPLICATION AND THE YES BOX MUST BE MARKED.
PHASE I: Demonstration of feasibility of the innovative approach.
Research should be proposed to provide sufficient information to support
a future Phase II application. If two years of support are requested,
the goals for the first year should be clearly stated and not simply a
reiteration of specific aims. Support for the second year will be
contingent upon NCI programmatic evaluation to ensure that investigators
are accomplishing the goals presented.
PHASE II: Continuing support for development of pre-clinical research
that may include establishment of proof of principle in clinical trials.
Support can be requested for pre-clinical developmental activities
including pharmacology, formulation and toxicology. Innovative aspects
of the research necessary to complete the projects such as development
of new in vivo evaluation models that may require surrogate endpoints
rather than traditional survival or tumor shrinkage models should be
clearly described. Support for clinical trial evaluation to establish
proof of principle (normally through Phase II development) can be
requested to commence following completion of the pre-clinical
activities and approval of the IND by the FDA. A plan for the clinical
trial should be presented in the RESEARCH PLAN section. If clinical
studies are planned in the first two years, IN THE HUMAN SUBJECTS
SECTION, INCLUDE THE COMPLETE CLINICAL PROTOCOL and DATA AND SAFETY
MONITORING PLAN. If it is premature to submit a complete clinical
protocol, a draft protocol may be submitted. Informed consent form(s)
must be included. NIH will treat as confidential any scientific, pre-
clinical, clinical or formulation data and information that the sponsor
deems to be proprietary and confidential. For each trial, provide a
Gender and Minority Inclusion Report in the format provided in the 398
form instructions:
http://grants.nih.gov/grants/funding/phs398/phs398.html.
If research has not progressed to the point where a clinical protocol
can be submitted with the application or by time of review but a
clinical trial would be likely in later years of the Phase II award,
clinical trial support should be requested in a competitive supplement
at the next appropriate FLAIR receipt date.
The goals and milestones for each year of support must be clearly
presented. Support for years two to four, if requested, is dependent
upon NCI programmatic review of progress and achievement of the proposed
goals. For example, if a goal cannot be achieved such as identification
of a more effective analog or demonstration of acceptable toxicity
cannot be demonstrated, additional years may not be supported.
This PAR encourages projects with aims focusing on later stages of drug
development such as formulation and toxicology as well as clinical
evaluation. However, accomplishing these aims may likely require
expertise not present in the applicant small business, and a sub-
contract site within the award may be required. Information on the drug
development process is available: http://dtp.nci.nih.gov and
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm.
Due to the complex nature of the drug development process, it is
recommended that only well defined and more advanced projects be
proposed for support with FAST-TRACK applications.
Phase I, FAST TRACK applications must specify clear, measurable
milestones that should be achieved prior to Phase II funding. Failure
to provide such information in the Phase I application and/or sufficient
detail in the Phase II application may be sufficient reason for the peer
review committee to exclude the Phase II from consideration. If so, the
applicant may apply later for Phase II support. Special provisions
described in this PAR pertaining to Phase I and Phase II also apply to
FAST-TRACK applications.
All Phase II applications, including those submitted as a FAST-TRACK,
must include a succinct Commercialization Plan. The Commercialization
Plan must be included as part of the Research Plan. Refer to Phase II
grant application instructions for more specific details and
instructions. See
http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf or
http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc.
Potential applicants are encouraged to contact NCI program staff for
guidance and to read the advice and information on the web sites.
However, responsibility for planning, direction, and execution of the
proposed research will be solely that of the applicant.
CONSULTANT AND CONTRACTUAL COSTS: Research expertise required to obtain
data for IND filing and FDA regulatory approval as well as conduct of
clinical trials likely may not be available at the small business and
thus will require a subcontract with an outside institution. Likewise
costs for this research may exceed the normal expectations for percent
of the total grant budget allocated to subcontracts. If adequately
justified, applications may exceed this guideline. Resources provided
for such research activity will be limited for that activity and cannot
be rebudgeted.
COMPETING CONTINUATION PHASE II APPLICATIONS: A competitive renewal of
Phase II for up to an additional three years may be requested for
current Phase II awards which have successfully discovered agents which
should be considered for development to clinical trial. Research
activities supported by the competing continuation award would be
expected to include an extension and expansion of pre-clinical
development that would be required for IND filing and FDA approval, as
well as support for a clinical trial. The Phase II competing
continuation should not be used to extend discovery research. All Phase
II provisions stated in this PAR, including budget limitations, apply to
the Phase II competitive renewal application. Since the Phase II
competing continuation grant is a new funding mechanism, eligible
applicants are strongly encouraged to contact their Program Director
prior to submission of an application.
COMPETING SUPPLEMENTS: A competing supplemental application may be
submitted at the receipt dates presented on page one of this PAR to
request support for a significant expansion of a project's scope,
research protocol, or to add a new specific aim. Phase II awardees who
wish to add research aims to obtain data required for IND filing or to
conduct clinical trials are encouraged to apply for supplemental
funding. Instructions for application can be found in the Omnibus
SBIR/STTR Solicitation Instructions. Awardees should consult with the
Program Director prior to submission of the supplement request.
ADMINISTRATIVE SUPPLEMENTS: Supplements to extend a peer reviewed and
funded specific aim for reasons that were unpredicted at the time of
application can be requested at any time. New aims to the award cannot
be added with this process. Examples appropriate for FLAIR would be,
but not limited to, requirement for additional toxicity studies
suggested by the FDA after the initial IND review or support for
unexpected clinical trial costs. Administrative supplement requests
should be discussed with and submitted to the Program Director.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original
of the application, including the checklist, and three signed
photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
To expedite the review process, at the time of submission, send two
copies of the application to:
Referral Officer
National Cancer Institute
6116 Executive Blvd, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER
INSTITUTE OR THE CENTER FOR SCIENTIFIC REVIEW WILL NO LONGER BE
ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX,
UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/
NOT-CA-02-002.html). This policy is published in the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
RECEIPT OF APPLICATIONS: Applications must be received on or before the
receipt date listed on the first page of this announcement. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
The Center for Scientific Research (CSR) will not accept any application
in response to this PAR that is essentially the same as one currently
pending initial review unless the applicant withdraws the pending
application. The CSR will not accept any application that is
essentially the same as one already reviewed. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a PAR, it is to be
prepared as a NEW application. That is the application for the PAR must
not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes. While
the investigator may still benefit from the previous review, the PAR
application is not to state explicitly how.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed by CSR staff for
completeness and by NCI program staff for adherence to guidelines.
Incomplete applications and applications not adhering to instructions
described above will be returned to the applicant without further
review.
Applications that are complete and adhere to the guidelines of this PAR
will be evaluated for scientific and technical merit and the documented
ability of the investigators to meet the RESEARCH OBJECTIVES of this PAR
by an appropriate peer review group convened by the NCI, in accordance
with the peer review criteria listed below.
For the merit review, all applications will:
o Receive a written critique
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Undergo a second level review by the National Cancer Advisory Board
for those that receive a priority score.
REVIEW CRITERIA
The goals of NIH-sponsored research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
Within this framework, the specific goals of this PAR include the
discovery and development of new cancer treatments within the SBIR and
STTR programs. In addition to the standard review criteria described in
the OMNIBUS SOLICITATION, reviewers will comment on the following
aspects of the application in their written critiques in order to judge
the likelihood that the proposed research will have a substantial impact
on the pursuit of these goals. Each criterion will be addressed and
considered by the reviewers in assigning the overall score weighting
them as appropriate for each application. Note that the application
does not need to be strong in all categories to be judged highly
meritorious. For example, an investigator may propose a development or
testing project that alone may not be highly innovative, but is required
for successful development of an innovative and potentially important
agent.
o Significance
o Approach
o Innovation
o Investigator
o Environment
ALL SBIR/STTR APPLICATIONS
1. SIGNIFICANCE: Does the proposed project have commercial potential to
lead to a marketable product or process? What may be the anticipated
commercial and societal benefits of the proposed activity? Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge be advanced? What will be the
effect of these studies on the concepts or methods that drive this
field? What is the potential clinical relevance of the research and
agents proposed?
2. APPROACH: Are the conceptual framework, design, methods, and
analyses adequately developed, well integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Is it likely that the drug or
vaccine can be developed in a reasonable time frame? Is the approach
feasible and cost effective? For systems intended for clinical research,
the following, additional criteria will be considered: to what degree is
the analysis appropriate for clinical research and likely to have
utility for the analysis of clinical specimens or patients?
3. INNOVATION: Does the project employ novel concepts, approaches, or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms? Are the new drugs or vaccines or their
proposed use novel?
4. INVESTIGATORS: Is the Principal Investigator capable of coordinating
and managing the proposed SBIR/STTR? Is the work proposed appropriate to
the experience level of the Principal Investigator and other
researchers, including consultants and subcontractors (if any)? Are the
relationships of the key personnel to the small business and to other
institutions appropriate for the work proposed?
5. ENVIRONMENT: Is there sufficient access to resources (e.g.,
equipment, facilities)? Does the scientific and technological
environment in which the work will be done contribute to the probability
of success? Do the proposed experiments take advantage of unique
features of the scientific environment or employ useful collaborative
arrangements?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See additional
information and criteria included in the section on Federal Citations,
below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See additional information and
Inclusion Criteria in the sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the required five items described under
Vertebrate Animals (section f of the Research Plan instructions) will be
assessed.
Human Subjects:
1. Protection of Human Subjects from Research Risks - for all studies
involving human subjects. See instructions and "Guidance for Preparing
the Human Subjects Research Section."
If an exemption is claimed, is it appropriate for the work proposed? If
no exemption is claimed, are the applicant's responses to the six
required points appropriate?
Are human subjects placed at risk by the proposed study? If so, are the
risks reasonable in relation to the anticipated benefits to the subjects
and others? Are the risks reasonable in relation to the importance of
the knowledge that reasonably may be expected to be gained?
Are the plans proposed for the protection of human subjects adequate?
2. Inclusion of Women Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of both genders that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent? Does
the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
3. Inclusion of Minorities Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of minorities that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent? Does
the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
4. Inclusion of Children Plan- for all studies involving human subjects.
Does the applicant describe an acceptable plan in which the
representation of children of all ages (under the age of 21) is
scientifically appropriate and recruitment/retention is addressed
realistically? If not, does the applicant provide an appropriate
justification for their exclusion?
5. Data and Safety Monitoring Plan – for clinical trials only. Does
the applicant describe a Data and Safety Monitoring Plan that defines
the general structure of the monitoring entity and mechanisms for
reporting Adverse Events to the NIH and the IRB?
Animal Welfare: If vertebrate animals are involved, are adequate plans
proposed for their care and use? Are the applicant's responses to the
five required points appropriate? Will the procedures be limited to
those that are unavoidable in the conduct of scientifically sound
research?
Biohazards: Is the use of materials or procedures that are potentially
hazardous to research personnel and/or the environment proposed? Is the
proposed protection adequate?
ADDITIONAL CONSIDERATIONS: The following items may be also be considered
by reviewers but will not be included in the determination of scientific
merit.
BUDGET: The reasonableness of the proposed budget may be considered.
For all applications, is the percent effort listed for the PI
appropriate for the work proposed? On applications requesting up to
$100,000 total costs, is the overall budget realistic and justified in
terms of the aims and methods proposed? On applications requesting over
$100,000 in total costs, is each budget category realistic and justified
in terms of the aims and methods?
PERIOD OF SUPPORT: The appropriateness of the requested period of
support in relation to the proposed research.
Phase II Application Review Criteria: In addition to the above criteria:
1. How well did the applicant demonstrate progress toward meeting the
Phase I objectives, demonstrating feasibility, and providing a solid
foundation for the proposed Phase II activity?
2. Did the applicant submit a concise Commercialization Plan [formerly
Product Development Plan] that adequately addresses the four seven areas
described in the Research Plan item J?
3. Does the project carry a high degree of commercial potential, as
described in the Commercialization Plan?
Amended Applications
In addition to the above criteria, the following criteria will be
applied to revised applications.
1. Are the responses to comments from the previous SRG review adequate?
2. Are the improvements in the revised application appropriate?
Phase I/Phase II Fast-Track Application Review Criteria
For Phase I/Phase II Fast-Track applications, the following criteria
also will be applied:
1. Does the Phase I application specify clear, appropriate, measurable
goals (milestones) that should be achieved prior to initiating Phase II?
2. Did the applicant submit a concise Commercialization Plan [formerly
Product Development Plan] that adequately addresses the seven areas
described in the Research Plan, item J?
3. To what extent was the applicant able to obtain letters of interest,
additional funding commitments, and/or resources from the private sector
or non-SBIR/ STTR funding sources that would enhance the likelihood for
commercialization?
4. Does the project carry a high degree of commercial potential, as
described in the Commercialization Plan?
Phase I and Phase II Fast-Track applications that satisfy all of the
review criteria will receive a single rating. Failure to provide clear,
measurable goals may be sufficient reason for the scientific review
group to exclude the Phase II application from Fast-Track review.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent: June 16, 2003 and October 17, 2003
Application Receipt Dates: July 14, 2003 and November 14, 2003
Council Review: February 2004 and June 2004
Earliest Anticipated Award Date: April 2004 and July 2004
AWARD CRITERIA
Applications submitted in response to a PAR will compete for available
funds with all other recommended SBIR and STTR applications. The
following will be considered in making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
FAST-TRACK, Phase II applications may be funded following submission of
the Phase I progress report and other documents necessary for
continuation. Phase II projects will be selected for funding based on
the initial priority score, Program staff's assessment of the Phase I
progress and determination that Phase I goals were achieved, the
project's potential for commercial success, and the availability of
funds.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be
gained.
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Clinical trials supported or performed by NCI require special
considerations. The method and degree of monitoring should be
commensurate with the degree of risk involved in participation and the
size and complexity of the clinical trial. Monitoring exists on a
continuum from monitoring by the principal investigator/project manager
or NCI program staff or a Data and Safety Monitoring Board (DSMB).
These monitoring activities are distinct from the requirement for study
review and approval by an Institutional review Board (IRB). For details
about the Policy for the NCI for Data and Safety Monitoring of Clinical
trials see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm.
For Phase I and II clinical trials, investigators must submit a general
description of the data and safety monitoring plan as part of the
research application. See NIH Guide Notice on "Further Guidance on a
Data and Safety Monitoring for Phase I and II Trials" for additional
information: http://grants.nih.gov/grants/guide/notice-files/
NOT-OD-00-038.html. Information concerning essential elements of data
safety monitoring plans for clinical trials funded by the NCI is available:
http://www.cancer.gov/clinical_trials/.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for
Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at http://
grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of
clinical research; updated racial and ethnic categories in compliance
with the new OMB standards; clarification of language governing NIH-
defined Phase III clinical trials consistent with the new PHS Form 398;
and updated roles and responsibilities of NIH staff and the extramural
community. The policy continues to require for all NIH-defined Phase
III clinical trials that: a) all applications or proposals and/or
protocols must provide a description of plans to conduct analyses, as
appropriate, to address differences by sex/gender and/or racial/ethnic
groups, including subgroups if applicable; and b) investigators must
report annual accrual and progress in conducting analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for research
involving human subjects. You will find this policy announcement in the
NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A
continuing education program in the protection of human participants in
research in now available online at: http://cme.nci.nih.gov/.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://grants.nih.gov/grants/stem_cells.htm and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom of
Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PAR in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This PAR is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review. Awards are made under the authorization
of Sections 301 and 405 of the Public Health Service Act as amended (42
USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement. The NIH Grants Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or
early childhood development services are provided to children. This is
consistent with the PHS mission to protect and advance the physical and
mental health of the American people.